Page 121 - EJMO-9-3

Eurasian Journal of
Medicine and Oncology Zercepac + pyrotinib versus pertuzumab in HER2+ BC
®

2.4. Safety assessment 3.3. Multivariate predictors of pCR

Adverse events were evaluated according to the World Multivariate logistic regression analysis demonstrated that
Health Organization Toxicity Grading Scale. The following both age and TNM stage independently influenced the
parameters were assessed: likelihood of achieving tpCR:
(i) Laboratory parameters: Complete blood count, (i) Patients aged >50 years had 3.82 times higher odds
hepatic/renal function, and electrolyte profiles. of achieving tpCR compared to those aged ≤50 years
(ii) Cardiac monitoring: Electrocardiogram (ECG) and (95% confidence interval [CI]: 1.104 – 13.225,
echocardiogram (performed quarterly). p=0.034).
(iii) Clinical symptoms: Alopecia, nausea/vomiting, (ii) Conversely, patients with advanced-stage (cTNM
diarrhea, abdominal pain, and arthralgia. IIb – IIIc) showed a 91.2% reduction in the odds of
achieving tpCR compared to those with stage IIa
Notably, no significant LVEF decline (>10%) or cardiac disease (odds ratio [OR] = 0.088, 95% CI: 0.023 –
dysfunction was observed. Cardiac events were defined as: 0.338, p<0.001) (Table 3).
(i) ST-T segment abnormalities.
(ii) Clockwise/counterclockwise rotation on ECG. 3.4. Univariate predictors of pCR
(iii) Premature atrial/ventricular contractions. Univariate analysis based on post-operative pathological
(iv) Sinus arrhythmia. assessment identified five significant predictors of tpCR
(v) Conduction block. achievement:
(vi) Low QRS voltage. (i) Advanced age (>50 years).
(vii) Left axis deviation. (ii) Clinical nodal involvement (cN ≥1).
(viii) Left ventricular hypertrophy. (iii) Advanced TNM stage (IIb – IIIc).
2.5. Statistical analysis (iv) Hormone receptor-negative status.
(v) Non-use of dual-target therapy.
Data were analyzed using SPSS 26.0 (IBM Corp.,
United States). Categorical variables were compared Detailed comparisons between tpCR and non-tpCR
using the chi-square test or Fisher’s exact test. Binary groups are presented in Table 4.
logistic regression was used to identify independent 3.5. Adverse events
clinicopathological predictors of neoadjuvant therapy
efficacy. A two-tailed p-value <0.05 was considered Treatment-related adverse events occurred in over 40% of
statistically significant. patients, with the most frequent being alopecia (91.7%),
followed by nausea (48.4%), diarrhea (41.9%), and fatigue
3. Results (35.5%). Cardiovascular events, though generally mild,
included arrhythmias (19.4%), T-wave abnormalities
3.1. Baseline clinicopathological characteristics
(12.9%), and transient LVEF fluctuations (a >10% change
The study cohort comprised 62 patients with HER2- in 6.5% of cases). Notably, no symptomatic heart failure or
positive breast cancer, classified into the following grade ≥3 cardiac events were observed (Table 5).
histopathological subtypes:
(i) Invasive ductal carcinoma: 45 cases (72.6%). 3.6. Comparative analysis of TCbHP versus TCbHPy
(ii) Invasive carcinoma with intraductal component: regimens
11 cases (17.7%). 3.6.1. Efficacy outcomes
(iii) Invasive carcinoma with ductal carcinoma in situ: Five No statistically significant differences were observed between
cases (8.1%).
(iv) Invasive carcinoma with mucinous features: One case the TCbHP and TCbHPy regimens (Table 6) in terms of:
(i) tpCR rate (55.2% versus 37.5%, p=0.25).
(1.6%).
(ii) Magnitude of Ki-67 index reduction (p=0.67).
Detailed baseline characteristics are presented in (iii) Miller–Payne pathological regression grading (p=0.07).
Table 1.
3.6.2. Safety profile
3.2. Predictors of pCR
While both regimens demonstrated comparable toxicity
Univariate logistic regression analysis identified age, profiles (Table 6), the incidence of diarrhea differed
tumor-node-metastasis (TNM) stage, and hormone markedly:
receptor (HR) status as independent predictors of total (i) TCbHPy group: 100% (8/8).
pCR (tpCR) (Table 2). (ii) TCbHP group: 3.4% (1/29) (p<0.001).

Volume 9 Issue 3 (2025) 113 doi: 10.36922/EJMO025100044